Lecturer (IAEA Expert Mission)

ORGAN DONATION ACT- Rep. Act 7170

(pending in congress) House bill : 7114 “An act establishing a Tissue Bank for collection and storage of human tissues and bone for transplantation”

Lack of funds

Limited tissue donors

Lack of public awareness

Inadequate government support

Protocol for Freeze Dried Radiation Sterilized Bone

	Bones are harvested and cleaned of all soft tissues
	They are cut into desired shape and sizes
	Washing
	Degreasing
	Freeze drying- 2-3 days with 30 mbars.
	Packaging in double seal plastic
	Sterilization by gamma radiation -2.5 mrads.

1984- Research project IAEA

1990- Tissue Bank bldg. at the UP - CM

1992- 4th APASTB Meeting- Manila

1992- First bone transplant

Cases Reconstruction:   

Unicondylar FemoralL

Total Distal Femur

Proximal Tibia

Proximal Humerus

Allograft-Athrodesis Reconstruction

	Knee
	Shoulder
	Ankle

Intercalary allograft reconstruction

	Femur
	Tibia
	Humerus

Allograft-Prosthesis Reconstruction

	Proximal femur
	Distal femur
	Proximal tibia
	Proximal humerus

INFECTION - 12%

FRACTURE - 6 months

28 months peaks

4 yrs. nil

NON-UNION -with chemo (methotrexate)

75 days w/o chemo

175 days w/ adriamycinendoxan

246 days T10 protocol

ALLOGRAFT RECONSTRUCTION IN ORTHOPEDIC ONCOLICAL SURGERY IS A VIABLE METHOD TO RESTORE SKELTAL DEFECTS.

METHODS MAY BE INDIVIDUALIZED TO SOLVE THE PROBLEM USING ALLOGRAFTS, PROSTHESIS AND AUTOGRAFTS OR COMBINATIONS.

History & Rationale:

19th century by McEwen

1908- Lexer E

1950- Curtis, Herndron and Chase- immune response is significantly reduced by freezing

since 1971 -500 allograft transplantation at Massachusetts General Hospital

	Appropriate sizes and shapes can be available.
	Joint replacement can be done.
	Soft tissue attachments may be made for function.
	Safe for donors site.
	Other forms of surgery may be done later.

The best results is only 85% of cases

High rate of fractures, nonunion, infection

No remodelling, so that implant can not be removed and fractures do not heal routinely

Sizing may be a problem Technically difficult procedure

TUMORS

NONTUMORS

FAILED ALLOGRAFT

TRAUMATIC LOSS

MASSIVE OSTEONECROSIS

FIBROUS DYSPLASIA

GAUCHERS

VILLONODULAR SYNOVITIS

PAGETS

                    EOSINOPHILIC GRANULOMAS

Tumor related (123 patients w/high grade tumors)

death-                       34 (27.6%)

Metastasis                 49 ( 39.8%)

Local recurrence         15 ( 12.2%)

Allograft Related Complications:

1.Infection            43 (10.7%)

2.Fracture              71 (17.7%)

3.Non-Union           58 (14.5%)

4.Joint instability  19 ( 6.7%)

-1,2,3, -Based on 401 cases

-4- based on 282 cases

Type	NO.	% Exce.	Good	Fair	Poor
Osteoarticular	232	37.9	35.8	1.7	24.5
Intercalary	77	71.4	15.6	0.0	13.0
Allo w/pros.	50	44.0	36.0	2.0	18.0
Allo w/arthro	42	0.0	69.1	2.4	2 8.6
Total	401	41.0	35.4	1.5	21.9

                                                                                                        

Out of 401, 307 (76.6%) had “SATISFACTORY “ RESULT

MASSIVE ALLOGRAFTS IN TUMORS OF CHILDREN

JBJS 1995 By, Alman, de Bari , Karjbich Toronto Canada

From 1982- 89

Osteosarcoma and Ewing’s sarcoma

Total of 26 patients

6- intercalary

16 resection arthrodesois

3- osteoarticular

entire replacement

69 % (18)-- GOOD AND EXCELLENT

15% (4) - FAIR

15% (4) - FAIR

Complications:

77% Had at least one complication

54% Sustained at least one fracture

12% Infected

PROCUREMENT OF TISSUES

Tissue Donation System:

Types of Tissue donation

A. Living donors

B. Cadaver donors

1-femoral heads

2-limbs from traumatic amputation

3-bone from osteotomy sites

Bones

	limbs
	ribs
	pelvis
	Ligaments
	Tendons
	Meniscus

	transplant coordinators
	internist
	surgeons
	pathologist
	forensic experts
	dentist
	Allied medical
	nurses
	medical technologist
	surgical technicians
	Non- medical:
	administrators
	legal counsels
	religious / social workers

TISSUE BANKS MAIN GOAL IS TO PROVIDE SAFE AND HIGH QUALITY TISUE GRAFTS.

- CAREFUL REVIEW OF DONORS MEDICAL AND SEXUAL HISTORY

- PHYSICAL EXAMINATION

          -LABORATORY EXAMINATION

	YOUNG HEALTHY ADULT UNDER 55 YRS. OLD
	NO INFECTION
	NO MALIGNANCY
	NO AUTOIMMUNE DISEASE
	NO STEROIDS

VDRL/RPR

Hepatitis B surface antigen

Hepatitis C antibodies

HIV antibody

Microbiological ( culture)

Tissues are preserved in their original viable state

Biomechanical properties are preserved

Contamination is minimized

Operating room set up

Logistics and resources

	OR equipment and supplies
	surgical instruments
	materials for storage
	reconstruction materials

	LOWER LIMB
	UPPER LIMB
	RIBS
	MANDIBLE

	Skin should not be taken from the hands, feet and areas above the chest
	Viable graft w/o sterilization within 4 hrs if at room temp.
	If the skin is to preserved by freeze drying, recovery must be done within 24 hrs. post mortem.

	DURA MATER
	FASCIA
	TENDON
	LIGAMENT
	AMNIONS
	CORNEA

	CORNEA by artificial eyeball
	SKIN by covering w/ gauze
	BONE by wood or plastic bones
	Reconstruction should be carried out with consideration to the culture and burial tradition in the community.

BONE ALLOGRAFTS - DEMINERALIZED BONE

LIVING DONOR-

	FEMORAL HEADS
	BONE FROM TKR
	OSTEOTOMY
	AMPUTATION
	HIV, HBV OR HCV CAN BE RETESTED

AFTER 3 MONTHS , ALTHOUGH FOLLOW UP MAY BE DIFFICULT

CADAVERIC DONOR

	CANCELLOUS AND CORTICO-CANCELLOUS
	CORTICAL BONE
	OSTEOCHONDRAL BONE
	BONE WITH LIGAMENTS AND TENDONS

FORM MAY BE REQUIRED BY THE SURGEON ENDUSER.

	POWDER
	CHIPS
	CUBES
	GRANULES
	MASSIVE ALLOGRAFTS
	BONE WITH SOFT TISSUE

	BAND SAW SHAKER
	FREEZE DRYER INCUBATOR
	REFRIGERATOR LABORATORY EQUIPMENT
	LIQUID NITROGEN
	LAMINAR AIR FLOW
	SEALER
	PLASTIC BAGS
	LYOPHILIZATION (FREEZE DRYING METHOD) BONES ARE CUT IN SHAPE WASHING BY WATER FREEZING FREEZE DRYING PACKAGING STERILIZATION

CRYOPRESERVATION OF CARTILAGE AND BONES BY : 7.5 - 10% DMSO TO PRESERVE THE VIABILITY OF CHONDROCYTES AND OSTEOCYTES

	ESSENTIALLY COLLAGEN FRAMEWORK WITH HYDROXYAPATITIE DEPOSITED
	MECHANICAL STRENGHT
	REDUCED MICROBIAL LOAD
	REDUCED ANTIGENICITY

	PROCURED UNDER STERILE CONDITION
	STORED IN PLASTIC- PAPER, GLASS CONTAINER
	STERILIZATION DONE BY RADIATION
	TEMPERATURE- MINUS 50-800 C

	COLD STORAGE- +40C to +100C - less than 48 hrs
	FROZEN -100C TO 200C - less than 6 months
	Frozen -500C to -800C - max. 5 yrs.

This preparation is extensively used by oral and maxillofacial surgeons implantologist, dental surgeons.

	WASHING WITH DISTILLED WATER
	DEFATTING W/ CHLOROFORM AND METHANOL
	MILLING THE BONE TO ADEQUATE SIZE
	FREEZE DRYING
	SIEVING THE BONE FOR POWDER FORM
	DEMINERALISATION - 0.5M HCL (250 ml/5g of bone) x 90min - centrifuge(>1500 rpm) for 5 min. 3X
	ADJUST pH to 6.9 with PBS
	FREEZE DRYING
	PACKING
	RADIATION STERILISATION (15-25 kG)
	LABELLING

	1668- Van Meekeren transplanted a dog’s cranium to a man
	1878- McEwan- did the first clinical allograft
	1895 Bart described bone healing- “creeping substitution
	United States Naval tissue bank
	1952 Flosdroff did freeze drying of bone
	1953- Urist described the bone morphogenic protein
	1971- Mankin used massive osteochondral allografts
	1976- American Association of Tissue Banks

	Young healthy adult under 55 yrs. old
	No infection or malignancy
	No steroids
	No exposure to toxic substances
	no treatment with hormones
	Unknown cause of death

	CUTTING TO SIZE
	WASHING
	DEGREASING
	FREEZE DRYING
	PACKAGING- LABELING
	STERILIZATION

	BOILING
	AUTOCLAVING
	EHTYLENE OXIDE
	IRRADIATION

	NO TEMPERATURE INCREASE
	NO CHEMICAL
	DOSE CONTROL IS EASY
	PRE-PACKAGING OF TISSUES
	EFFECTIVE
	SAFE

	FOR LIMB SALVAGE SURGERIES
	STERILE PROCUREMENT
	RADIATION STERILIZATION
	PRESERVED BY DEEP FREZZING

	FOR BONE CYST
	NONUNIONS
	ARTHRODESIS
	AUGMENTATION

	NO NEED FOR 2ND OPERATION
	LESS BLOOD LOSS
	NO WEAKNESS OF OTHER BONES
	NO NEED FOR EXTRA ANESTHESIA
	LESS AREA FOR INFECTION
	TIME SAVING

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